SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Director, Statistical Programming
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
Director, Statistical Programming
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
SeniorEDC Programmer
Bothell, WA · On-site
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
SeniorEDC Programmer
Bothell, WA · On-site
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
Key Responsibilities Lead statistical programming activities across global studies Serve as primary programming lead in collaboration with Biostatistics Develop, review, and validate SDTM and ADaM ...
Key Responsibilities Lead statistical programming activities across global studies Serve as primary programming lead in collaboration with Biostatistics Develop, review, and validate SDTM and ADaM ...
Principal Programmer, Statistical Programming
San Diego, CA · On-site
$154K - $195K/yr
The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures. * Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions ...
Quick apply
Principal Programmer, Statistical Programming
San Diego, CA · On-site
$154K - $195K/yr
The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures. * Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
... SDTM. • Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. • Develop programs and utilities using various tools and languages to ...
... SDTM. • Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. • Develop programs and utilities using various tools and languages to ...
Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses. * Manage CROs and contractors, ensuring compliance ...
Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses. * Manage CROs and contractors, ensuring compliance ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Data Scientist
Carolina Beach, NC · On-site
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
Data Scientist
Carolina Beach, NC · On-site
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Develop SDTM datasets conforming to CDISC standards; Develop Analysis Data Model datasets conforming to CDISC standards as required. * Develop and update as required by CDISC Reviewer's Guides.
Quick apply
Develop SDTM datasets conforming to CDISC standards; Develop Analysis Data Model datasets conforming to CDISC standards as required. * Develop and update as required by CDISC Reviewer's Guides.
Senior Statistical Programmer - Remote
Fairfield, CT · On-site +1
Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses Provide programming support to internal ...
Senior Statistical Programmer - Remote
Fairfield, CT · On-site +1
Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses Provide programming support to internal ...
Director, Statistical Programming
OR · Remote
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
Director, Statistical Programming
OR · Remote
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards * Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
Quick apply
Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards * Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards. * Ensure the timely and high-quality ...
Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards. * Ensure the timely and high-quality ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
Durham, NC · On-site
$98K - $273K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Associate Director, Statistical Programming
$229K - $269K/yr
Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and and output displays * Validate ...
Associate Director, Statistical Programming
$229K - $269K/yr
Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and and output displays * Validate ...
SAS Programmer III
South San Francisco, CA · On-site
$74/hr
Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADaM datasets. Understand and execute department-, product- and study-level macros and utilities. Write, test ...
SAS Programmer III
South San Francisco, CA · On-site
$74/hr
Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADaM datasets. Understand and execute department-, product- and study-level macros and utilities. Write, test ...
Sdtm information
See salary details
$19.23 - $24.78
4% of jobs
$24.78 - $30.33
9% of jobs
$30.33 - $35.88
4% of jobs
$35.88 - $41.43
7% of jobs
$41.78 is the 25th percentile. Wages below this are outliers.
$41.43 - $46.98
9% of jobs
The median wage is $52.53 / hr.
$46.98 - $52.53
17% of jobs
$52.53 - $58.09
7% of jobs
$58.09 - $63.64
14% of jobs
$65.40 is the 75th percentile. Wages above this are outliers.
$63.64 - $69.19
12% of jobs
$69.19 - $74.74
10% of jobs
$74.74 - $80.29
7% of jobs
$19
$54
$80
How much do sdtm jobs pay per hour?
What is an SDTM job?
An SDTM job involves working with the Study Data Tabulation Model (SDTM), a standardized format required by regulatory agencies like the FDA for clinical trial data submission. Professionals in this role convert raw clinical data into SDTM-compliant datasets, ensuring consistency, traceability, and adherence to regulatory guidelines. Responsibilities often include data mapping, validation, and quality control to facilitate efficient review by regulatory bodies.
What are the key skills and qualifications needed to thrive in the Sdtm position, and why are they important?
To thrive as an SDTM (Study Data Tabulation Model) Programmer, you need a strong background in clinical data standards, SAS programming, and an understanding of FDA submission requirements, usually supported by a degree in a scientific, mathematical, or computer-related field. Expertise with CDISC standards, SDTM IGs (Implementation Guides), and tools such as Pinnacle 21 Validator or JReview is essential. Strong analytical skills, attention to detail, effective communication, and the ability to collaborate across multidisciplinary teams are vital soft skills. These competencies are crucial for ensuring high-quality, regulatory-compliant clinical trial data that supports successful drug approval processes.
What are the typical daily responsibilities of an SDTM Programmer in a clinical research organization?
As an SDTM Programmer, your daily tasks often include mapping raw clinical data into SDTM domains, validating datasets for compliance with CDISC standards, and generating documentation and specifications for regulatory submissions. You’ll frequently work with clinical data managers, statisticians, and other programmers to ensure data integrity and resolve any data-related queries that arise. Collaboration and timely troubleshooting are key, as your work supports the efficient progression of clinical studies through regulatory review. The role tends to be dynamic and deadline-driven, making organizational skills and adaptability important for success.

Other
Medical, Dental, Vision, Life, Retirement, PTO
Posted 29 days ago
United Airlines rating
7.8
Based on 333 frontline employees who took The Breakroom Quiz
9th of 26 rated airlines
Job description
At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.
The Life Sciences industry is undergoing dramatic changes, impacted by patent expirations, patient empowerment, increased regulatory scrutiny, and stringent cost containment. While the industry continues to lower costs and consolidate, it is seeking new growth opportunities through innovation, diversification, and expansion in emerging markets. Capgemini Invent's Life Sciences practice has partnered with leading pharmaceutical and biotechnology clients to help define and deliver their future state for more than 25 years. The dedicated team guides clients from strategy to execution across the value chain. The practice's core focus areas are commercial and digital transformation, innovation, business agility, patient services, and patient experience.
Skilled across the product lifecycle, the team brings deep experience in early commercialization, product launch, brand growth, and lifecycle management. The team's consultants help drive change and transform organizations. Leaders in digital transformation, the team has helped clients establish innovation incubators, develop digital medicine strategies, enhance patient experiences, and identify new revenue sources.
- Clinical Data Management & CDISC Compliance: SDTM, ADaM, Define.xml, CDASH (with SEND awareness).
- EDC Systems & Optimization: Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations (CTMS, safety, eTMF, IRT).
- Database Design & Specifications: CRF design, data dictionaries, derivation rules, edit check logic, SDTM/ADaM mapping.
- Data Quality & Integration: Validation (Pinnacle 21/OpenCDISC), data migration to CDISC, quality metrics monitoring, reconciliation and traceability.
- Assess current-state processes; identify gaps and design future-state workflows (build, cleaning, queries, lock).
- Validate datasets and remediate standards deviations; ensure source-to-analysis traceability.
- Collaborate with biostatistics on derived endpoints and analysis-ready datasets.
- Prepare submission artifacts (reviewer's guides, Define.xml, annotated CRFs) aligned with FDA/EMA expectations.
- Contribute technical content to proposals and discovery workshops.
- Build reusable assets: CDISC checklists, EDC design best practices, SOP templates, query management guides.
- Track standards and regulatory updates (SDTM, ADaM, CDASH, SEND; electronic submission expectations).
- Mentor junior consultants on CDISC, EDC capabilities, and data quality.
- Support recruiting with technical interviews and candidate assessments.
- 6-10 years in clinical data management with CDISC implementation and EDC/database design.
- Hands-on EDC platforms (e.g., Rave, Vault EDC, Clinical One/Inform, Medrio, REDCap).
- Proficiency with validation tools (Pinnacle 21, OpenCDISC).
- Technical skills: SQL, SAS (CDISC conversions), plus R/Python exposure; Excel; familiarity with Tableau/Power BI/Spotfire.
- Knowledge of ICH-GCP, 21 CFR Part 11, and data integrity principles.
- Strong analytical, communication, and consulting skills.
- Bachelor's in a relevant field; Master's preferred. U.S. work authorization (no sponsorship).
- CDISC/CDM certifications (CDMP, CCDM).
- Pharma/CRO experience across multiple trials and regulatory submissions (IND/NDA/BLA).
- Experience with system integrations (EDC CTMS, safety, eTMF, labs).
- Understanding of SAPs/biostatistics; exposure to RWD, wearables, and AI/ML for data quality.
You'll have the opportunity to:
- Build a network within the Capgemini Group and contribute to the education of other Business Units around practice offerings to support existing account expansion
- Play a significant role in client proposals and RFI/RFP responses from initial brief to final sales presentations
- Nurture and expand existing account relationships
- Identify potential personal business relationships that can be leveraged by the practice to develop new business
- Identify potential project extension and expansion opportunities while staffed on projects
- Support the development of thought leadership and innovative offerings as they relate to AI/Data Science, Digital Customer Analytics, and Operational Analytics.
- Support the upskilling of the team members on topics related to Data & Analytics
The base compensation range for this role in the posted location is: $112,600 to $160,000
Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.
The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.
These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.
Disclaimers
Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
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About United Airlines
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United Airlines is embarking on an exciting journey to become the best airline in aviation history. Our purpose, "Connecting People, Uniting the World," extends beyond transportation, emphasizing our commitment to uplift and create opportunities in the places we serve. With a global presence and diverse workforce, we value inclusivity and are dedicated to hiring tens of thousands of individuals across various roles. Our comprehensive benefits package, including perks like space available travel, parental leave, and 401k, aims to support your well-being and growth.
Industry
Aviation
Company size
10,000+ Employees
Headquarters location
Chicago, IL, US
Year founded
1926